Autism Genomics Sweden - Genetic Guidance and Information Trial

Last updated: August 5, 2025
Sponsor: Karolinska Institutet
Overall Status: Completed

Phase

N/A

Condition

Anxiety Disorders

Autism

Asperger's Disorder

Treatment

Genetic counselling

Leaflet

Clinical Study ID

NCT06740760
2023-06737-01
  • Ages 15-30
  • All Genders

Study Summary

This observational clinical trial aims to evaluate whether providing genetic information about the origins of autism and related psychiatric disorders enhances understanding, well-being, and empowerment in adolescents and young adults with autism. The study will compare the outcomes of two groups: one receiving a 1.5-hour genetic counseling session with a clinician and the other receiving general genetic information via a leaflet. Participants will be assessed using pre- and post-intervention questionnaires, including measures of understanding of their condition (mGCOS-24) and mental health (GAD-7 and PHQ-9). The study also explores whether mental health factors like anxiety and depression influence the effectiveness of the interventions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants aged 15 - 30 years of age.

  • Living in Sweden.

  • Able to consent independently or with guardian consent if necessary.

  • Understanding of Swedish-language questions.

  • Interest in receiving genetic counselling information on autism.

Exclusion

Exclusion Criteria:

  • Participants unwilling to complete pre- or post-intervention surveys.

  • Participants unwilling to participate in either form of genetic counseling

Study Design

Total Participants: 63
Treatment Group(s): 2
Primary Treatment: Genetic counselling
Phase:
Study Start date:
June 15, 2024
Estimated Completion Date:
July 31, 2025

Study Description

The goal of this observational clinical study is to assess whether receiving genetic information about the origins of autism and related neuropsychiatric disorders, either at a population level or as individual information after genetic testing, can improve understanding of their condition, well-being, and empowerment in adolescents and young adults with autism spectrum condition (ASC). The main questions to answer are:

  • Does a genetic counseling session improve participants' understanding of autism and its origins, well-being, and empowerment as measured by the modified Genetic Counseling Outcome Scale (mGCOS-24)?

  • Is the outcome modified by mental health indicators such as anxiety and depression measures, and does the information improve these?

  • We will also assess how genetic knowledge and beliefs before the genetic information session affect the main outcome of the mGCOS-24 change.

The comparison will be made between the group receiving a 1.5-hour genetic counseling session with a clinician and a group receiving general genetic information via leaflet by email to see if the genetic information session by the clinician leads to greater improvements in understanding, empowerment, and well-being.

Participants will:

  • Answer basic demographic questionnaire as well as a questionnaire about genetic knowledge and beliefs

  • Be randomized to receive a 1-1.5 hour genetic counseling session in person or online, or general genetic information via leaflet.

  • Complete pre- and post-intervention questionnaires, including the mGCOS-24, GAD-7, and PHQ-9.

Connect with a study center

  • Karolinska Institutet

    Stockholm,
    Sweden

    Site Not Available

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